Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Snak King Corporation recalls O-Organic Sea Salt Popcorn due to milk allergen found in the production line's recycle chute. Consumers with milk allergies should not consume this product.
Karl Storz is recalling flexible bronchoscopes due to potential failure of the disinfection process. The devices may not eliminate microorganisms adequately, posing an infection risk to patients.
Ethicon is recalling STRATAFIX surgical sutures (lots AAHM529 and AAHQ049) due to component mix-ups resulting in incorrect needle types, sizes, or suture lengths. 2,808 units distributed internationally are affected.
Lucid is recalling 2022 Air vehicles because the display wiring harness may not be secured properly, potentially disabling screens that show speedometer, gear selection, and warning lights.
Amgen is recalling specific lots of MVASI (bevacizumab-awwb) injection due to a loose crimp defect in the container that could compromise container integrity. Patients should contact their healthcare provider.
Daavlin's 4 Series CX phototherapy units are recalled due to a software defect that can cause incorrect dosing (over or under) when resuming interrupted treatments.
Eastland Food Corporation is recalling Bwell Bird's Nest Beverage in Lychee Flavor due to deficient packaging material that could lead to premature spoilage. Approximately 1,699 cases were distributed to retail stores across 33 states.
The Philips Hemodynamic Application, Model 722463, may not automatically switch to neonatal mode for blood pressure monitoring, potentially applying excessive cuff pressure that could cause bruising, nerve damage, or bone deformity in newborns.
Synthes has updated safety instructions for its Radial Head Replacement System implant with absolute contraindications for use in patients with infection, sepsis, or osteomyelitis. The FDA has classified this as a Class II recall.
Microtek Medical Inc. is recalling TMJ Arthroscopy Drapes that contain latex but were mislabeled as latex-free, posing an allergic reaction risk to patients and healthcare workers with latex sensitivities.
American Contract Systems is recalling ACS Spine Pack and ACS Lumbar/Back Set Up Tray surgical instrument sets due to improper sterilization with excess ethylene oxide. The affected sets were distributed in Illinois, Missouri, Nebraska, and Texas.
Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope (FLEX-XC) models because they may fail to achieve adequate disinfection, creating potential microbial contamination risk.
Karl Storz is recalling HD-VIEW Flexible HD Cysto-Urethroscope models that fail to adequately disinfect during processing, creating a potential infection risk. All units manufactured since January 2018 are affected.
The FDA is recalling KARL STORZ Slim Nasopharyngolaryngoscope models 11001RD1 and 11001RDK1 because they fail to achieve adequate disinfection, potentially allowing microorganisms to persist on the device and transmit between patients.
Karl Storz Flexible Cystoscope units may not be properly disinfected because the disinfection process fails to achieve the expected reduction of microorganisms. All units manufactured since January 2018 are potentially affected.
The ACS IR Angio Pack from American Contract Systems, Inc. was sterilized using ethylene oxide at higher than specification concentration. No illnesses or injuries have been reported.
Mylan Institutional Inc. is recalling Esomeprazole Magnesium Delayed-Release Capsules 20 mg due to failed impurity specifications detected during stability testing. 555 cartons of affected lots were distributed nationwide.
Daavlin is recalling 1 Series CX phototherapy units due to a software bug that swaps calibration distance settings when resuming interrupted treatments, resulting in incorrect dosing.
Shanghai United Imaging's digital X-ray systems may display reversed spine positioning labels, potentially causing misdiagnosis and unnecessary repeat radiation exposure for patients.
Karl Storz is recalling multiple Flexible Video Urethro Cystoscope models because they may fail to achieve proper disinfection between procedures, posing a risk of microbial contamination.
Karl Storz Endoscopy is recalling Flexible Video Cysto-Urethroscopes due to a disinfection process failure that may not adequately eliminate microorganisms. Affected units have been distributed nationwide and internationally since January 2018.
Mosaic Food Company is recalling Curry Vinaigrette due to Salmonella contamination in the onions used to manufacture the product. The affected lot 24421 was distributed in California.
Olympus is issuing updated instructions for reprocessing its EVIS EXERA bronchovideoscopes to ensure proper sterilization and disinfection procedures. Improper reprocessing could compromise device safety.
American Contract Systems recalls ACS Lap Chole Pack surgical kits due to sterilization with ethylene oxide concentration exceeding manufacturer specification.
Karl Storz Endoscopy is recalling flexible ureteroscopes manufactured or distributed since January 2018 due to the disinfection process failing to achieve expected microbial reduction levels.